What’s Your Study? Navigating IRB Submission Forms

Transcript:What’s Your Study? Navigating IRB Submission Forms:
What’s Your Study? Navigating IRB Submission Forms & Resources Kelly Quesnelle Ph.D., IRB Chair Learning Objectives Participants will be able to: List the three criteria that must be met for study to be considered human subjects research and describe how to apply to the IRB for a determination of whether a study is human subjects research. List the two criteria that must be met for quality improvement and program evaluation studies to be considered regulated research and describe how to apply to the IRB for a determination of whether a study is regulated research. List the six categories of regulated research that are exempt from IRB review and describe how to apply to the IRB for an exemption determination. Identify the three most common errors that investigators make when submitting research for an exemption determination. Compare expedited reviews and full board reviews with a specific focus on documents required for IRB submission and categories of research that are eligible for expedited review. TYPES OF IRB DETERMINATIONS Not Regulated Research Not Human Subjects Research (NHSR) Quality Assurance/Quality Improvement (QA/QI) – Not Regulated Research Regulated Research Exempt from IRB Review Studies Requiring IRB Review convened board or expedited DETERMINATIONS vs. APPROVALS Not Regulated Research Not Human Subjects Research (NHSR) Quality Assurance/Quality Improvement (QA/QI) – Not Regulated Research Regulated Research Exempt from IRB Review Studies Requiring IRB Review convened board or expedited Review for Determination & Basic Ethical Considerations Full Review for Approval DETERMINATIONS vs. APPROVALS Not Regulated Research Not Human Subjects Research (NHSR) Quality Assurance/Quality Improvement (QA/QI) – Not Regulated Research Regulated Research Exempt from IRB Review Studies Requiring IRB Review convened board or expedited Review for Determination & Basic Ethical Considerations Full Review for Approval Not Human Subjects Determination ALL OF THE FOLLOWING CRITERIA MUST BE MET TO BE CONSIDERED HUMAN SUBJECTS RESEARCH: The research involves living individuals. The investigator will obtain data or information about those individuals. The investigator will obtain EITHER of the following: Data through intervention or interaction with the individuals. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Identifiable private information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,